Anvil Assembly Delivery Systems

ABSTRACT

An anvil assembly suitable for trans-oral delivery includes an anvil head configured to receive a retrieval suture that is separable from the anvil head following delivery of the anvil assembly. An anvil delivery assembly includes the anvil assembly, a delivery assembly secured to the anvil assembly, and a retrieval suture selectively secured to the anvil assembly for retrieving the anvil assembly.

BACKGROUND

1. Technical Field

The present disclosure relates to an anvil assembly for use with asurgical stapling device. More particularly, the present disclosurerelates to a delivery system for trans-oral delivery of the anvilassembly.

2. Background of Related Art

Trans-oral delivery systems for delivering an anvil assembly to asurgical site, e.g., the stomach, are known. In known delivery systems,a guide suture is threaded through one or more openings in the head ofthe anvil assembly to facilitate trans-oral insertion of the anvilassembly. The guide suture which include ends that remain external ofthe patient's mouth, may be used by the surgeon to dislodge the anvilassembly if it becomes stuck during trans-oral delivery and/or toretrieve the anvil assembly in the event of a patient emergency, e.g.,cardiac arrest. Improved methods for securing the guide suture to ananvil assembly to facilitate detachment of the guide suture from theanvil assembly once the anvil assembly is delivered to the surgical siteand/or the stapling procedure has been performed would be desirable.

SUMMARY

An anvil delivery system is provided. The system includes a deliveryassembly and an anvil assembly selectively securable to the deliveryassembly. The anvil assembly includes a center rod assembly and a headassembly pivotally secured to the anvil center rod about a pivot axisand movable between a first tilted position, an operative position, anda second tilted position. The head assembly including a housing, acutting ring, and an anvil plate, the housing defining a throughborepassing through the housing and between the cutting ring and the anvilplate. The anvil delivery system further includes a retaining sutureselectively secured between the head assembly and the delivery assemblyfor retaining the head assembly in the first tilted position and aretrieval suture received through the throughbore of the housing andhaving at least one end extending distally from the anvil assembly.

In some embodiments, the retrieval suture extends the length of thecenter rod assembly. The delivery member may include a flexible tube andan adapter member. The retrieval suture may be frictionally securedbetween the flexible tube and the adapter member. The retrieval suturemay include a loop and the retaining suture being received through theloop. Alternatively, the retrieval suture is received about the centerrod assembly. The retrieval suture may extend across the cutting ringwhen the head assembly is in the operative position.

Also provided is a method of securing a guide suture to an anvilassembly. The method includes providing an anvil assembly including acenter rod assembly and a head assembly, the head assembly defining atleast one throughbore, receiving a first end of a retrieval suturethrough the at least one throughbore, forming a loop in the retrievalsuture, and receiving the first end of the retrieval suture through theat least one throughbore. The method may further include attaching ananvil delivery system to a distal end of the center rod assembly andsecuring the loop in the retrieval suture to the anvil delivery system.Forming the loop in the retrieval suture may include wrapping the firstend of the suture around a retaining suture. Forming the loop in theretrieval suture may instead include wrapping the first end of thesuture around the center rod assembly. The method may further includereceiving the loop in the retrieval suture about the center rodassembly.

Another method of securing a guide suture to an anvil assembly isprovided. The method includes providing an anvil assembly including acenter rod assembly and a head assembly pivotally secured to the centerrod assembly, the head assembly defining a throughbore, receiving a loopof a retrieval suture through the throughbore in the head assembly ofthe anvil assembly, and securing the loop relative to the head assembly.Securing the loop relative to the head assembly may include attaching ananvil delivery system to the center rod assembly and securing the loopof the retrieval suture between the center rod assembly and the deliverysystem. Securing the loop relative to the head assembly may insteadinclude selectively securing a retaining suture to the head assembly andreceiving the retaining suture through the loop in the retrieval suture.Alternatively, securing the loop relative to the head assembly includesreceiving the loop of the retrieval suture about the center rodassembly.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed anvil assembly and anvilassembly delivery system are disclosed herein with reference to thedrawings wherein:

FIG. 1 is a perspective view of a surgical stapling device including anembodiment of an anvil assembly according to the present disclosure;

FIG. 2 is a first perspective side view of the anvil assembly of FIG. 1;

FIG. 3 is a second perspective side view of the anvil assembly shown inFIGS. 1 and 2;

FIG. 4 is an exploded side view of the anvil assembly of FIGS. 1-3;

FIG. 5 is an end view of the anvil assembly of FIGS. 1-4;

FIG. 6 is a cross-sectional side view of a distal end of the tilt anvilassembly of FIGS. 1-6 taken along line 6-6 of FIG. 5;

FIG. 7 is a cross-sectional side view of a distal end of the anvilassembly of FIGS. 1-6 taken along line 7-7 of FIG. 5;

FIG. 8 is an enlarged side view of the cam latch member of the anvilassembly of FIGS. 1-7;

FIG. 9 is a top view of the anvil assembly of FIGS. 1-7 supported on ananvil delivery system;

FIG. 10 is an enlarged exploded view of the anvil delivery system ofFIG. 9;

FIG. 11 an enlarged top view of the anvil delivery system of FIGS. 9 and10, including the anvil assembly of FIGS. 1-7;

FIG. 12 is a cross-sectional side view of the anvil assembly and anvilassembly delivery system of FIG. 11 taken along lines 12-12 of FIG. 11;

FIG. 13 is a cross sectional side view of the anvil assembly of FIGS.1-7, in a pre-fired tilted position supported on the anvil deliverysystem of FIGS. 9-12;

FIG. 14 is an enlarged view of the indicated area of detail shown inFIG. 13;

FIG. 15 is an illustration of the anvil assembly and anvil deliverysystem of FIGS. 11 and 12 being inserted trans-orally into a patient;

FIG. 16 is an enlarged side view of the distal head portion of thesurgical stapling device of FIG. 1 with the anvil assembly removed;

FIG. 17 is an enlarged side view of the distal head portion of thesurgical stapling device of FIG. 1 with the anvil assembly of FIGS. 1-7received thereon;

FIG. 18 is an enlarged cross-sectional side view of the distal headportion of the surgical stapling device of FIG. 1 and the anvil assemblyof FIGS. 1-7 in a pre-fired non-tilted operative position;

FIG. 19 is an enlarged cross-sectional side view of the distal headportion of the surgical stapling device of FIG. 1 and the anvil assemblyof FIGS. 1-7 in a post-fired non-titled operative position;

FIG. 20 is an enlarged cross-sectional side view of the distal end ofthe anvil assembly of FIGS. 1-7 in the post-fired operative position;

FIG. 21 is an enlarged cross-sectional side view of the distal end ofthe anvil assembly of FIGS. 1-7 in a post-fired tilted position;

FIG. 22 is a cross-sectional side view of the anvil assembly of FIGS.1-7 in a post-fired tilted position supported on an anvil retainer ofthe surgical instrument of FIG. 1;

FIG. 22A is another cross-sectional side view of the anvil assembly ofFIGS. 1-7 in a post-fired tilted position supported on an anvil retainerof the surgical instrument of FIG. 1

FIG. 23 is an enlarged view of the indicated area of detail shown inFIG. 22A;

FIG. 24 is a side view of the anvil assembly of FIG. 22 supported on theanvil retainer of the surgical stapling device of FIG. 1;

FIG. 25 is a perspective top view of an anvil assembly according toanother embodiment of the present disclosure in the first tiltedposition;

FIG. 26 is a perspective bottom view of the anvil assembly of FIG. 25;

FIG. 27 is a perspective top view of the anvil assembly of FIG. 25including first and second sutures arranged in a first configuration;

FIG. 28 is a perspective bottom view of the anvil assembly and sutureconfiguration of FIG. 27;

FIG. 29 is a perspective top view of the anvil assembly of FIG. 25including first and second sutures arranged in a second configuration;

FIG. 30 is a perspective bottom view of the anvil assembly and sutureconfiguration of FIG. 29;

FIG. 31 is a perspective top view of the anvil assembly of FIG. 25including first and second sutures arranged in a third configuration;

FIG. 32 is a perspective bottom view of the anvil assembly and sutureconfiguration of FIG. 31.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed anvil assembly delivery systemwill now be described in detail with reference to the drawings in whichlike reference numerals designate identical or corresponding elements ineach of the several views. Throughout this description, the term“proximal” will refer to the portion of the instrument closest to theoperator and the term “distal” will refer to the portion of theinstrument furthest from the operator.

FIG. 1 illustrates an embodiment of a surgical stapling deviceconfigured for use with tilt anvil assemblies according to the presentdisclosure. Briefly, surgical stapling device 10 includes a proximalhandle assembly 12, an elongated central body portion 14 including acurved elongated outer tube 14 a, and a distal head portion 16.Alternately, in some surgical procedures, e.g., the treatment ofhemorrhoids, it is desirable to have a substantially straight,shortened, central body portion. The length, shape and/or the diameterof body portion 14 and distal head portion 16 may also be varied to suita particular surgical procedure.

With reference still to FIG. 1, handle assembly 12 includes a stationaryhandle 18, a firing trigger 20, a rotatable approximation knob 22 and anindicator 24. A pivotally mounted trigger lock 26 is fastened to handleassembly 12 and is manually positioned to prevent inadvertent firing ofstapling device 10. Indicator 24 is positioned on the stationary handle18 and includes indicia, e.g., color coding, alpha-numeric labeling,etc., to identify to a surgeon whether the device is approximated and isready to be fired. Head portion 16 includes an anvil assembly 110 and ashell assembly 31. For a more detailed discussion of surgical stapler10, please refer to commonly owned U.S. Pat. No. 7,364,060 to Milliman,the contents of which is incorporated herein by reference in itsentirety.

Referring now to FIGS. 2-7, an anvil assembly according to an embodimentof the present disclosure is shown generally as anvil assembly 110.Anvil assembly 110 is shown in a non-titled position or operativeposition. Anvil assembly 110 includes a head assembly 112 and a centerrod assembly 114. Head assembly 112 includes a post 116, a housing 118,a backup member or plate 120, a cutting ring 122, a cutting ring cover123, an anvil plate 124, a spacer or washer 125, a cam latch member 126,and a retainer member 127. Post 116 is monolithically formed with andcentrally positioned within housing 118. Alternately, housing 118 andpost 116 may be formed separately and fastened together using a knownfastening technique, e.g., welding.

As will be discussed in further detail below, housing 118 includesopenings 119 a, 119 b sized and dimensioned to receive one or moresutures “S”. During use, a first suture “S₁” (FIG. 9) is insertedthrough openings 119 a and is used to retain head assembly 112 in aretracted or first tilted position (FIG. 9) during insertion of anvilassembly 110 within a patient. A second suture “S₂” (FIG. 9) is insertedthrough openings 119 b. The second suture “S₂” is configured tofacilitate guiding tilt anvil assembly 110 trans-orally within apatient. During trans-oral insertion of anvil assembly 110, suture “S₂”extends from the mouth of patient, permitting the anvil assembly 110 tobe retrieved trans-orally.

With reference still to FIGS. 2-7, anvil plate 124 is supported in anouter annular recess 128 of housing 118 and includes a plurality ofstaple deforming pockets 130 for receiving and deforming staples. Atleast one tab 124 a extends radially outwardly from anvil plate 124 andis received within a cutout 132 formed in an outer rim of housing 118.Tab 124 a and cutout 132 function to align or properly position anvilplate 124 within annular recess 128 of housing 118.

With particular reference to FIGS. 6 and 7, head assembly 112 will bedescribed in detail. Backup plate 120 includes a central opening 134which is positioned about post 116 within an inner annular recess 136 ofhousing 118 between post 116 and outer annular recess 128. Backup plate120 includes a raised platform 120 a. Cutting ring 122 includes anopening 122 a having a configuration substantially the same as platform120 a. Although platform 120 a is illustrated as having a circularshape, other configurations are envisioned, e.g., square, rectangular,triangular, etc. In one embodiment, cutting ring 122 is formed frompolyethylene and is fixedly secured to backup plate 120 using, forexample, an adhesive, to form a backup plate/cutting ring assembly.Backup plate 120 is formed from a hard material, e.g., a metal.Alternately other materials of construction may be used to constructbackup plate 120 and cutting ring 122. Further, backup plate 120 andcutting ring 122, in the alternative, can be formed as a single orunitary structure.

Still referring to FIGS. 6 and 7, a cutting ring cover 123 is secured toan outwardly facing or proximal surface of cutting ring 122 using, forexample, an adhesive. In one embodiment, cutting ring cover 123 isformed from a material or materials, which have a hardness greater thanthat of the cutting ring, e.g., mylar. In one embodiment, cutting ringcover 123 includes two layers of mylar (not shown) which are joinedtogether using an adhesive and a polypropylene coating. Alternately,cutting ring 122 need not have a cover. Cutting ring 122 and backupplate 120 are slidably mounted about post 116. Backup plate 120 includesa pair of inwardly extending fingers 138 which will be described infurther detail below.

With reference still to FIGS. 6 and 7, retainer member 127 is positionedin inner annular recess 136 between backup plate 120 and a back wall 118a of housing 118. In one embodiment, retainer member 127 is annular andincludes a plurality of deformable tabs 127 a which engage a rearsurface of backup plate 120. Retainer member 127 prevents backup plate120 and cutting ring 122 from moving or being pushed into inner annularrecess 136 of housing 118 until a predetermined force sufficient todeform tabs 127 a has been applied to the backup plate/cutting ringassembly. The predetermined force can be close to but is less than theforce applied by an annular cutting blade of a surgical stapling devicewhen it engages, for example, the cutting ring of anvil assembly 110. Inone embodiment by way of example, the predetermined force is betweenabout ten pounds and about ninety pounds and can be about thirty (30)pounds. When the predetermined force is reached, e.g., during cutting oftissue, backup plate 120 is urged into inner annular recess 136 andcompresses retainer member 127. It is envisioned that other crushable,deformable, collapsible or movement restricting members may be used toretain the backup plate/cutting ring assembly in a fixed position untila predetermined force has been applied to the backup plate/cutting ringassembly.

Turning back to FIG. 4, anvil center rod assembly 114 includes a centerrod 152, a plunger 154 and plunger spring 156. A first end of center rod152 includes a pair of arms 159 which define a cavity 159 a. Each arm159 has a transverse throughbore 158 which is aligned with a centrallongitudinal axis of center rod 152. Alternately, throughbores 158 canbe offset from the longitudinal axis of center rod 152. Post 116 ofanvil head assembly 112 is dimensioned to be positioned within cavity159 a and also includes a transverse throughbore (not shown). A pivotmember 162 pivotally secures post 116 to center rod 152 via the throughbores such that anvil head assembly 112 may be pivotally mounted toanvil center rod assembly 114.

Turning briefly to FIG. 8, cam latch member 126 includes a body 126 ahaving a throughbore 126 b. Throughbore 126 b is dimensioned to receivepivot member 162 such that cam latch member 126 is pivotally mountedwithin transverse slot 172 (FIG. 3) of post 116 about pivot member 162.Referring now to FIGS. 3, 6 and 7, cam latch member 126 includes a firstbody portion 126 c which extends partially from slot 172 of post 116 andis positioned to be engaged by a finger 166 of plunger 154. First bodyportion 126 c is configured such that the distance between the surfaceof first body portion 126 c and through bore 126 b increase in aclockwise direction about cam latch member 126. In this manner, plunger154 is able to move forward as cam latch member 126 rotates in aclockwise direction. Additionally, this configuration of first bodyportion 126 c permits plunger 154 to be retracted as cam latch memberrotates in a counter-clockwise direction. Cam latch member 126 alsoincludes an edge 126 f, including a tab 126 b. A leading portion of edge126 f is configured to be urged into engagement with an inner periphery120 b of backup plate 120 by an engagement finger 166 of plunger 154when anvil head 112 is in its non-tilted or operative position. Tab 126g is configured to engage backwall 118 a of housing 118 to prevent camlatch member 126 from rotating counter-clockwise relative to housing118.

With reference to FIG. 6, plunger 154 is slidably positioned in a bore164 formed in the first end of center rod 152. Plunger 154 includes anengagement finger 166 which is offset from the pivot axis of anvil headassembly 112 and biased into engagement with an edge 126 c of cam latch126. Engagement of finger 166 with edge 126 c of cam latch 126 presses aleading portion of edge 126 f against an inner periphery of back plate120 to urge anvil head assembly 112 to an operative or non-tiltedposition on center rod 152.

Turning to FIG. 7, in the pre-fired operative position of head assembly112, i.e. when head assembly 112 has been pivoted to its non-tiltedposition, fingers 138 formed on backup plate 120 engage protrusions 152b adjacent top surface 152 a of center rod 152 to prevent head assembly112 from pivoting about pivot member 162. Anvil head assembly 112 may betilted α degrees (FIG. 13) relative to anvil center rod assembly 114 inthe pre-fired tilted position. In one embodiment, anvil head assembly112 is tilted about seventy degrees (70°) in its pre-fired tiltedposition; however it should be understood that tilting head assembly 112to other degrees is also contemplated. Titling of anvil head assembly112 relative to anvil center rod assembly 114 causes body portion 126 cof cam latch member 126 to engage finger 166 of plunger 154. As camlatch assembly 126 rotates with the tilting of anvil head assembly 112,plunger 154 is retracted with bore 164 of anvil center rod assembly 114,thereby compressing spring 156. In this manner, finger 166 of plunger154 is distally biased against body portion 126 c of cam latch member126.

With reference to FIGS. 3 and 4, a second end of center rod 152 includesa bore 180 defined by a plurality of flexible arms 182. Flexible arms182 each include an opening 182 a dimensioned to receive a projectionformed on or connected to a shell assembly 31 (FIG. 18). Alternatively,openings 182 a may be configured to receive a suture for permittingretrieval of anvil assembly 110. The proximal ends of each of theflexible arms 182 include an internal shoulder 184 dimensioned toreleasably engage shell assembly 31 of surgical stapling device 10 tosecure anvil assembly 110 to the surgical stapling device. A pluralityof splines 186 are formed about center rod 152. Splines 186 function toalign anvil assembly 110 with the staple holding portion of a surgicalstapling device. Center rod 152 also includes an annular recessedportion 190 to facilitate grasping of anvil assembly 110 by a surgeonwith a grasper. Recessed portion 190 may include a roughened or knurledsurface or an overmold to facilitate grasping of anvil assembly 110.

With reference now to FIGS. 9-12, a system for delivering anvil assembly110 within a patient is shown generally as anvil delivery system 50.Anvil delivery system 50 includes a flexible tube 52 and an adapter 62.Flexible tube 52 includes an open end 52 a. Adapter 62 and anvilassembly 110 are supported on open end 52 a of flexible tube 52. Openend 52 a of flexible tube 52 includes a through bore 53 extendingtherethrough configured to receive a locking pin 54. Open end 52 afurther includes an opening 55. Closed end 52 b of flexible tube 52 isconfigured for trans-orally receipt in a patient. Flexible tube 52 mayinclude markings or other gradations 56 along the length thereof toindicate to a surgeon how much of flexible tube 52 has been receivedwithin the patient during insertion and/or to indicate the length offlexible tube 52 remaining in the patient upon removal.

With particular reference to FIG. 10, adapter 62 includes a first end 62a configured to be received within open end 52 a of flexible tube 52 anda second end 62 b is configured to be received with in bore 180 formedin center rod 152 of anvil assembly 110. First end 62 a includes aseries of annular rings 64 configured to frictionally retain first end62 a of adapter 62 within open end 52 a of flexible tube 52. Second end62 b of adapter 62 includes a longitudinal guide member 66 configured tobe received between flexible arms 182 formed in center rod 152 of anvilassembly 110. In addition, second end 62 b of adapter 62 is sized toallow center rod 154 of anvil assembly 110 to freely slide into and offsecond end 62 b of adapter 62. Adapter 62 further includes a firstthrough bore 70 formed in a central hub portion 62 c as well as secondand third through bores 72, 74 formed in first end 62 a. Through bore 72is configured to align with through bore 53 formed in open end 52 a offlexible tube 52 and is sized to receive locking pin 54.

With particular reference now to FIGS. 10, 13 and 14, anvil assembly 110is supported on anvil delivery system 50. Securing anvil assembly 110 toanvil delivery system 50 requires first that suture “S₁” is threadthrough openings 119 a formed on anvil head 112 such that first andsecond ends of suture “S₁” are positioned on opposites of center rod152. Next, second end 62 b of adapter 62 is positioned within throughbore 180 of center rod 152 such that longitudinal guide 66 is receivedbetween two of arm members 182. Each of the first and second ends ofsuture “S₁” is inserted through opening 55 formed in open end 52 a offlexible member 52. Anvil head 112 is then rotated to a first tiltedposition while first and second ends of suture “S₁” are pulled throughopening 55. First end 62 a of adapter 62 is then inserted into open end52 a of flexible member. The frictional contact between annular rings 64of first end 62 a of adapter 62 and an inner surface of flexible tube 52secures adapter 62 to flexible tube 52 and prevents suture “S₁” fromloosening. It is envisioned that more than one suture may be used tosecure anvil head assembly 112 in a pre-fired tilted position.

With reference now to FIG. 15, a method for delivering anvil assembly110 to a surgical site within a patient will be described. In onemethod, anvil assembly 110 is provided in the first tilted positionsupported on anvil delivery system 50 and ready for delivery.Alternatively, a clinician secures anvil assembly 110 to anvil deliverysystem 50 as discussed above. Once anvil assembly 110 has been securedto flexible tube 52, the surgeon inserts closed end 52 b of flexibletube 52 in the patient's mouth “M” and moves closed end 52 b along withflexible tube 52 down through esophagus “E” to a surgical site, i.e.,the stomach “St”.

After insertion, the surgeon then makes a first incision “I₁” at thesurgical site (stomach “St” as shown) to create an inner access toclosed end 52 b of flexible tube 52 and then pulls open end 52 b offlexible tube 52 through first incision “I₁”. In some procedures it maybe beneficial to pull flexible tube 52 through incision “I₁” untilcenter rod 152 of anvil assembly 110 advances through first incision“I₁”. When anvil assembly 110 is properly positioned at the surgicalsite, the surgeon releases anvil delivery system 50 from anvil assembly110 by cutting suture “S₁” and separating anvil assembly 110 from secondend 62 b of adapter 62. Flexible tube 52 (with fitting 62) may then bepulled from the body through first incision “I₁”.

Severing of suture “S₁” permits plunger 154 to extend from within bore164, thereby causing finger 166 to engage body portion 126 c of camlatch member 126. Rotation of cam latch member 126 causes edge 126 f oflatch member 126 to move into engagement with the inner periphery ofbackup plate 120, thereby urging anvil head assembly 112 to return to anon-tilted operative position. Additionally, the distal end of staplingdevice 10 may be configured to engage finger 166 of plunger 154 as anvilassembly 110 is attached to surgical stapling device 10. In this manner,the distal end of surgical stapling device 10 urges plunger 154distally, thereby ensuring the rotation of anvil head assembly 112 to anon-tilted position.

With particular reference to FIG. 15, in one method, a second incision“I₂” is then formed at the surgical site such that distal head portion16 of surgical stapling device 10 may be received therethrough.Alternatively, distal head portion 16 of surgical stapling device 10 maybe received through first incision “I₁” once anvil deliver system 50 hasbeen removed therefrom.

Turning briefly to FIGS. 16 and 17, anvil assembly 110 is operablyreceived on an anvil retainer 32 extending from shell assembly 31 formedon a distal end of surgical stapling device 10. Once anvil assembly 110is received on surgical stapling device 10, surgical stapling device 10operates in the manner discussed in the '060 patent.

The operation of anvil assembly 110 will now be described with referenceto FIGS. 18-23. When anvil assembly 110 is in its pre-fired non-tiltedposition, backup plate 120 is spaced from backwall 118 a of housing 118by retainer 127 and protrusions 152 b of center rod 152 engage fingers138 of backup plate 120 to prevent tilting of anvil head assembly 112about pivot member 162. Finger 166 of plunger 154 is urged by spring 156into engagement with body portion 126 c of cam latch member 126 to urgecam latch member 126 in a clockwise direction, about pivot member 162such that edge 126 f of cam latch member 126 engages inner periphery 120b of backup member 120.

The firing of surgical stapling device 10 causes a knife blade 33thereof to engage cutting ring 122 to move cutting ring 122 and backupplate 120 into annular recess 136 of housing 118 of anvil head assembly112. Arrows “W” in FIG. 19 indicate how cutting ring 122 and backupplate 120 move as a result of the firing of surgical stapling device 10.When such movement occurs, deformable tabs 127 a of retainer 127 aredeformed against backwall 118 a of housing 118 and fingers 138 of backupmember 120 move away from protrusions 152 b of center rod 152. Further,inner periphery 120 b of backup plate 120 moves past edge 126 f of camlatch member 126 such that cam latch member 126 is urged to pivot aboutpivot member 162 in the direction indicated by arrow “X” in FIG. 21 byplunger 154 to a position in which body portion 126 d is positioned infront of and engages backup plate 120. Engagement of plunger 154 withcam latch member 126 urges anvil head assembly 112 to a second tiltedposition (FIGS. 22 and 23). It is noted that anvil head assembly 112will not immediately tilt upon firing of surgical stapling device 10because, upon firing, anvil head assembly 112 is in an approximatedposition, i.e., the anvil head assembly 112 is in close alignment withshell assembly 31 of stapling device 10, and, therefore, does notprovide room for head assembly 112 to pivot. As such, the anvil headassembly 112 will only begin to tilt when anvil assembly 110 and shellassembly 31 of surgical stapling device 10 are being unapproximated.

As anvil head assembly 112 pivots towards its forward or second tiltedposition, finger 166 of plunger 154 maintains surface 126 e of cam latchmember 126 in contact with backup plate 120 to prevent backup plate 120from sticking to the knife blade as the knife blade is retracted. It isnoted that curved surface 126 e of cam latch member is configured toeliminate any gap and ensure contact between surface 126 e of cam latchmember 126 and backup plate 120 to hold backup plate 120 in place duringand after the knife blade is retracted such that the cutting ring andbackup plate assembly stay in their correct position during continuedtilting of anvil assembly 112. Anvil assembly 110 is configured suchthat anvil head assembly tilts to a forward or second tilted position βdegrees (FIG. 23) relative to center rod assembly 114. In oneembodiment, anvil head assembly 112 is tilted about seventy degrees(70°) to its second tilted position such that the total pivotingmovement of the anvil from the retracted or first tilted position to theforward or second tilted position is about one-hundred and forty degrees(140°). It should, however, be noted that the tilting of anvil headassembly 112 to other degrees is also contemplated.

As described above, the anvil assemblies of the present disclosure areconfigured to be delivered to a surgical site, e.g., the stomach “St”(FIG. 15), trans-orally. During trans-oral delivery of the anvilassemblies, a retaining suture, i.e., first suture “S₁”, retains thehead assembly of the anvil assembly in a first tilted position and aproximal guide suture, i.e., second suture “S₂”, which includes firstand second ends “S_(2a)”, “S_(2b)” that remain external of the patient'smouth “M”, permits the surgeon to dislodge or retrieve the anvilassembly 110 from the patient during trans-oral delivery.

As described above and with reference to FIG. 11, second suture “S₂” isthreaded through openings 119 b in housing 118 of head assembly 112 ofanvil assembly 110. Detaching second suture “S₂” from anvil assembly 110requires pulling on first end “S_(2a)” of second suture “S₂” such thatsecond end “S_(2b)” of second suture “S₂” travels from a locationexternally of the patient's mouth “M” (FIG. 15) where it is accessibleby the surgeon, through the patient's mouth “M” and uppergastrointestinal (GI) tract, e.g., esophagus “E” and stomach “St” (FIG.15) (collectively referred to as the patient's body lumen) and throughthe openings 119 b in housing 118 of head assembly 112 of anvil assembly110 before having to travel back through the upper GI tract and out thepatient's mouth “M”.

With reference now to FIGS. 25-32, an anvil assembly according toalternate embodiment of the present disclosure is shown generally asanvil assembly 210. As will be described in further detail below, thesecond suture “S₂” is secured to anvil assembly 210 in variousconfigurations that permit detaching of the second suture “S₂” from theanvil assembly 210 following trans-oral delivery of anvil assembly 210by pulling on both first and second ends “S_(2a)”, “S_(2b)” of secondsuture “S₂”. In this manner, the second end “S_(2b)” of second suture“S₂” does not travel through the patient's mouth “M” (FIG. 15), upper GItract, e.g., esophagus “E” (FIG. 15) and stomach “St” (FIG. 15) duringwithdrawal. The various configurations for securing second suture “S₂”to anvil assembly 210 and the methods for securing the second suture“S₂” in the various configurations will be described as related to anvildelivery system 50 (FIG. 11) described hereinabove. However, it isenvisioned that aspects of the various configurations may be modifiedfor use with various anvil assemblies and anvil delivery systems, andthat the anvil assemblies can be used in any of the embodimentsdisclosed herein, or with any circular stapling apparatus such asrobotic, powered, reusable, manual, etc.

Referring to FIGS. 25 and 26, anvil assembly 210 is substantiallysimilar to anvil assembly 110 (FIG. 2) described hereinabove andincludes head assembly 212 and a center rod assembly 214. A housing 218of head assembly 212 defines a pair of openings 217 for receiving firstsuture “S₁” (FIG. 27). Housing 218 further defines a pair ofthroughbores 219 a, 219 b which pass through an outer surface 218 a ofhousing 218 and extend between a cutting ring 222 of head assembly 212and an anvil plate 224 (staple forming pockets not shown) of headassembly 212. As will be described in further detail below, secondsuture “S₂” may be threaded through either and/or both of throughbores219 a, 219 b.

FIGS. 27 and 28 illustrate a first configuration for securing secondsuture “S₂” to anvil assembly 210. In the first configuration, firstsuture “S₁” is received through openings 217 in housing 218 of headassembly 212 of anvil assembly 210 and is secured to anvil deliverysystem 50 (FIG. 11) as described above and shown in FIGS. 11-13.Briefly, and with reference back to FIG. 13, first and second ends“S_(1a)”, “S_(1b)” of first suture “S₁” are received through open end 52a of flexible member 52 of anvil delivery system 50 and through opening55 formed in flexible member 52. Insertion of the first end 62 a ofadapter 62 of anvil delivery system 50 into open end 52 a of flexiblemember 52 frictionally secures first and second ends “S_(1a)”, “S_(1b)”of first suture “S₁” to anvil delivery system 50. First and second ends“S_(2a)”, “S_(2b)” of second suture “S₂” are threaded in a distaldirection through respective first and second throughbores 219 a, 219 bof housing 218 to form a loop “L” at a midpoint of the second suture“S₂”. The second suture “S₂” is secured to anvil delivery system 50(FIG. 13) by positioning the loop “L” through opening 55 in flexiblemember 52 and frictionally securing the loop “L” between adapter 62 andflexible member 52.

Although shown as having first end “S_(2a)” of second suture “S₂”received through first throughbore 219 a and a second end “S_(2b)” ofsecond suture “S₂” received through second throughbore 219 b, it isenvisioned that both first and second ends “S_(2a)”, “S_(2b)” of secondsuture “S₂” may be received in a distal direction through either ofthroughbores 219 a, 219 b or that loop “L” of second suture “S₂” may bereceived in a proximal direction through either of throughbores 219 a,219 b. Further, although the second suture “S₂” is shown as a singlesuture having a midpoint secured to the anvil delivery system 50 andfirst and second ends “S_(2a)”, “S_(2b)” extending distally from anvilassembly 210, it is envisioned that second suture “S₂” may include afirst end (not shown) extending distally from anvil assembly 210 and asecond end (not shown) secured to anvil delivery system 50 (FIG. 13).

Following trans-oral delivery of anvil assembly 210 to a surgical site,e.g., stomach “St” (FIG. 15), first suture “S₁” is cut to allow headassembly 212 of anvil assembly 210 to pivot to a non-tilted or operativeposition (not shown) as discussed above with respect to anvil assembly110. When first suture “S₁” is cut, second suture “S₂” may also be cutto bisect the second suture “S₂”. Bisecting or cutting the second suture“S₂” in half facilitates removal of the second suture “S₂” from apatient's body in two pieces which are withdrawn through first andsecond throughbores 219 a, 219 b and from within the patient through thepatient's mouth “M” (FIG. 15) without first pulling one end of thesecond suture “S₂” through the patient's body lumen.

FIGS. 29 and 30 illustrate a second configuration for securing secondsuture “S₂” to anvil assembly 210. A loop “L” formed in second suture“S₂” is threaded in a proximal direction through, for example, first orsecond throughbore 219 a, 219 b in housing 218 of head assembly 212 ofanvil assembly 210. First suture “S₁”, after being threaded throughopenings 217 in housing 218 of head assembly 212 of anvil assembly 210,is threaded through the loop “L” in second suture “S₂” prior to beingsecured to anvil delivery system 50 (FIG. 11) as described above. Inthis manner, second suture “S₂” is securely attached to anvil assembly210 by first suture “S₁”, i.e., the first suture “S₁” is positionedthrough the loop “L” to prevent removal of the second suture “S₂”through the respective throughbore 219 a, 219 b. Alternatively, afterhead assembly 212 of anvil assembly 210 is retained in the first tiltedposition by first suture “S₁”, a first end “S_(2a)” of second suture“S₂” is threaded in a proximal direction through first or secondthroughbore 219 a, 219 b, wrapped around first suture “S₁”, and isthreaded through first or second throughbore 219 a, 219 b.

Following trans-oral delivery of anvil assembly 210 to a surgical site,e.g., stomach “St” (FIG. 15), first suture “S₁” is cut to allow headassembly 210 to pivot to the non-tilted or operative position (notshown). At this time, first suture “S₁” is detachable from head assembly212 of anvil assembly 210. Detaching first suture “S₁” from anvilassembly 210 removes first suture “S₁” from within loop “L” of secondsuture “S₂” freeing second suture “S₂” to be withdrawn through therespective throughbore 219 a, 219 b in housing 218 of anvil headassembly and from within the patient directly through the patient'smouth “M” (FIG. 15). Alternatively, loop “L” may be cut by the surgeonto free second suture “S₂” prior to cutting first suture “S₁”.

FIGS. 31 and 32 illustrate a third configuration for securing secondsuture “S₂” to anvil assembly 210. The first suture “S₁” is secured toanvil delivery system 50 (FIG. 11) in the manner described above tosecure head assembly 212 of anvil assembly 210 in the first tiltedposition. Securing the head assembly 212 in the first tilted positionmay occur prior to or after securing second suture “S₂” to anvilassembly 210.

As shown, a first end “S_(2a)” of second suture “S₂” is threaded throughone of throughbores 219 a, 219 b, for example, first throughbore 219 a,looped around center rod assembly 214 of anvil assembly 210 to form aloop “L”, and threaded through second throughbore 219 a. Although shownbeing received through different throughbores 219 a, 219 b, first andsecond ends “S_(2a)”, “S_(2b)” of second suture “S₂” may be receivedthrough the same throughbore 219 a, 219 b. As shown in FIG. 32, loopingsecond suture “S₂” about center rod assembly 214 causes second suture“S₂” to cross over cutting ring 222 of head assembly 212 of anvilassembly 210 in two locations.

In an alternative method of securing second suture “S₂” to anvilassembly 210 in the third configuration, a loop formed in second suture“S₂” is threaded in a proximal direction through one of first or secondthroughbores 219 a, 219 b and the loop is received over center rodassembly 214 of anvil assembly 210. After positioning the loop overcenter rod assembly 214, second suture “S₂” is retracted by pulling onfirst and second ends “S_(2a)”, “S_(2b)” of second suture “S₂” to removethe slack in second suture “S₂”.

Following trans-oral delivery of anvil assembly 210 to a surgical site,e.g., stomach “St” (FIG. 15), anvil assembly 210 is separated from anvildelivery system 50 (FIG. 11) and is secured to stapling device 10(FIG. 1) in the manner described above. Separation of anvil assembly 210from anvil delivery system 50 allows head assembly 212 of anvil assembly210 to pivot to the operative position (FIG. 17). Anvil assembly 210remains in the operative position during attachment to stapling device10. In the operative position (not shown), second suture “S₂” continuesto cross over cutting ring 222 of head assembly 212 of anvil assembly210.

Firing of stapling device 10 in the manner described above causes knifeblade 33 (FIG. 19) of stapling device 10 to advance into engagement withcutting ring 222 of head assembly 212 of anvil assembly 210. Sincesecond suture “S₂” crosses over cutting ring 222 in two locations,during firing of stapling device 10 second suture “S₂” is severed byknife blade 33 in two locations, resulting in second suture “S₂” beingcut into three lengths. The length of second suture “S₂” received aboutcenter rod assembly 214 is removed with the waste tissue cut during thestapling procedure. The remaining portions of second suture “S₂” arewithdrawn directly through throughbores 219 a, 219 b and from within thepatient by pulling independently on first and second ends “S_(2a)”,“S_(2b)” of second suture “S₂”.

Thus, the suture can be attached in a way to enable the circular knifeto cut the suture to free the suture so that it can be removed. Inaddition, the suture can be tied so as to facilitate removal of thesuture.

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary embodiments. It is envisioned thatthe elements and features illustrated or described in connection withone exemplary embodiment may be combined with the elements and featuresof another without departing from the scope of the present disclosure.As well, one skilled in the art will appreciate further features andadvantages of the disclosure based on the above-described embodiments.Accordingly, the disclosure is not to be limited by what has beenparticularly shown and described, except as indicated by the appendedclaims.

What is claimed is:
 1. An anvil delivery system comprising: a deliveryassembly; an anvil assembly selectively securable to the deliveryassembly, the anvil assembly including: a center rod assembly; a headassembly pivotally secured to the anvil center rod about a pivot axisand movable between a first tilted position, an operative position, anda second tilted position, the head assembly including a housing, acutting ring, and an anvil plate, the housing defining a throughborepassing through the housing and between the cutting ring and the anvilplate; a retaining suture selectively secured between the head assemblyand the delivery assembly for retaining the head assembly in the firsttilted position; and a retrieval suture received through the throughboreof the housing and having at least one end extending distally from theanvil assembly.
 2. The system of claim 1, wherein the retrieval sutureextends the length of the center rod assembly.
 3. The system of claim 1,wherein the delivery member includes a flexible tube and an adaptermember.
 4. The system of claim 3, wherein the retrieval suture isfrictionally secured between the flexible tube and the adapter member.5. The system of claim 1, wherein the retrieval suture includes a loop,the retaining suture being received through the loop.
 6. The system ofclaim 1, wherein the retrieval suture is received about the center rodassembly.
 7. The system of claim 1, wherein the retrieval suture extendsacross the cutting ring when the head assembly is in the operativeposition.
 8. A method of securing a guide suture to an anvil assemblycomprising: providing an anvil assembly including a center rod assemblyand a head assembly, the head assembly defining at least onethroughbore; receiving a first end of a retrieval suture through the atleast one throughbore; forming a loop in the retrieval suture; andreceiving the first end of the retrieval suture through the at least onethroughbore.
 9. The method of claim 8, further including attaching ananvil delivery system to a distal end of the center rod assembly andsecuring the loop in the retrieval suture to the anvil delivery system.10. The method of claim 8, wherein forming the loop in the retrievalsuture includes wrapping the first end of the suture around a retainingsuture.
 11. The method of claim 8, wherein forming the loop in theretrieval suture includes wrapping the first end of the suture aroundthe center rod assembly.
 12. The method of claim 8, further includingreceiving the loop in the retrieval suture about the center rodassembly.
 13. A method of securing a guide suture to an anvil assemblycomprising: providing an anvil assembly including a center rod assemblyand a head assembly pivotally secured to the center rod assembly, thehead assembly defining a throughbore; receiving a loop of a retrievalsuture through the throughbore in the head assembly of the anvilassembly; and securing the loop relative to the head assembly.
 14. Themethod of claim 13, wherein securing the loop relative to the headassembly includes attaching an anvil delivery system to the center rodassembly and securing the loop of the retrieval suture between thecenter rod assembly and the delivery system.
 15. The method of claim 13,wherein securing the loop relative to the head assembly includesselectively securing a retaining suture to the head assembly andreceiving the retaining suture through the loop in the retrieval suture.16. The method of claim 13, wherein securing the loop relative to thehead assembly includes receiving the loop of the retrieval suture aboutthe center rod assembly.